NCT02192840 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Gil RJ, Vassilev D, Formuszewicz R, Rusicka-Piekarz T, Doganov A
The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only. J Interv Cardiol. 2009 Dec;22(6):E1-E10. doi: 10.1111/j.1540-8183.2009.00492.x. Epub 2009 Aug 20.
Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wójcik J, Lesiak M, Kardaszewicz P, Lekston A
Dedicated paclitaxel-eluting bifurcation stent BiOSS® (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012 Jul 20;8(3):316-24. doi: 10.4244/EIJV8I3A50.
Iakovou I, Ge L, Colombo A
Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review.
Vassilev D, Gil R, Kwan T, Nguyen T, Nanjundappa A, Doganov A
Extension distance mismatch--an unrecognized factor for suboptimal side branch ostial coverage in bifurcation lesion stenting. J Interv Cardiol. 2010 Aug;23(4):305-18. doi: 10.1111/j.1540-8183.2010.00574.x. Epub 2010 Jul 19.
Vassilev D, Gil R
Clinical verification of a theory for predicting side branch stenosis after main vessel stenting in coronary bifurcation lesions. J Interv Cardiol. 2008 Dec;21(6):493-503. doi: 10.1111/j.1540-8183.2008.00400.x. Epub 2008 Oct 21.

Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

Details for clinical trial NCT02192840

Clinical trial NCT02192840 - References